Bringing a medical device to market is expensive. According to Makower and colleagues, patients are denied or delayed access to major medical devices that are first (or exclusively) marketed in other countries. Despite the enormous need to develop medical products that are considerably less expensive than traditional technologies, there are relatively few companies developing such products. Failure of medical devices, especially permanently implanted ones, carries a considerable risk of serious harm.
While product development is a costly undertaking in itself, it is especially so in a highly regulated environment such as the medical device industry. And for those studies that were not of the cardiovascular system (which was universally identified by participants as the most expensive medical device PAS to run). Medical device commercialisation is a multi-diligence test that includes market size, technology risk, regulatory pathway, intellectual property and medical economics. Therefore, we sought to develop cost estimates for medical device PASs by generating a cost model that could be used to predict the cost of a proposed or completed PAS.
The researchers identified these experts based on their reputation and experience in the field of medical device development and research. The considerable annual costs of PASs, borne by the public through the costs of the medical devices themselves, can provide relatively modest informational value to the medical community, the public and industry regulators. In most cases, the medical device company will consult with the FDA early in the process to choose the right pathway and avoid wasting time and costs. The vast majority of sophisticated medical devices are marketed through the 510(k) pathway, which requires a product to be substantially equivalent to an already marketed product.
Another complication is that it is difficult to develop an entirely new type of medical device because of the potential difficulty in obtaining reimbursement from government payers and insurance companies. He said that as long as these medical products are appropriately labelled, and as long as there are reasonable assurances of safety and efficacy for these products, they will be used appropriately by physicians. For devices that are low or moderate risk, but do not have a predicament in the marketplace, the medical device company can work with the FDA to explore alternative ways to bring the device to market if the clinical trial data are not justified.